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CTRI Number  CTRI/2025/07/090555 [Registered on: 09/07/2025] Trial Registered Prospectively
Last Modified On: 09/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Studying the Role of Indicated Homoeopathic Medicines in Controlling Type-2 Diabetes Mellitus  
Scientific Title of Study   An Analytical Study to Ascertain the Effectiveness of Indicated Homoeopathic Medicines in the Management of Type-2 Diabetes Mellitus with Using Purposive Sampling Technique 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Milan Badrinarayan Jayswal 
Designation  PG Scholar 
Affiliation  C.D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  C.D.Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  8849353679  
Fax    
Email  milan8849353679@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh P Khatri 
Designation  Associate Professor of Homoeopathic Materia Medica Department 
Affiliation  C.D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  C.D.Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9429012500  
Fax    
Email  mukeshkhatri5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mukesh P Khatri 
Designation  Associate Professor of Homoeopathic Materia Medica Department 
Affiliation  C.D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  C.D.Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat

Surat
GUJARAT
395001
India 
Phone  9429012500  
Fax    
Email  mukeshkhatri5@gmail.com  
 
Source of Monetary or Material Support  
C.D.Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat India 395001 
 
Primary Sponsor  
Name  C.D. Pachchigar College of Homoeopathic Medicine and Hospital 
Address  C.D.Pachchigar College of Homoeopathic Medicine and Hospital Near Navjivan Circle Udhana Magdalla Road Surat 395001 Gujarat India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Milan Badrinarayan Jayswal  C.D.Pachchigar College of Homoeopathic Medicine and Hospital  Department of Homoeopathic Materia Medica Post Graduation Division 2nd Floor
Surat
GUJARAT 
8849353679

milan8849353679@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of C.D.Pachchigar College of Homoeopathic Medicine and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicines  Individualized Homoeopathic Medicines Will be Prescribe on the basis of Totality of Symptoms. The Dose and Potency Will be Selected on the Basis Patient Susceptibility and Necessity of Case. Medicine Administration will be through Oral Route. Follow up will be Taken in 2-3 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  31.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients With Freshly Diagnosed And taking Antidiabetic Medicine Such as Metformin and Sitagliptin Since 12-24 Months are Included. But Antidiabetic Medicine Will be Tappered Down Slowly After Administration of Homoeopathic Medicines.
2.Antidiabetic Medicines will be Tappered Down on Basis of Improving Criteria.
 
 
ExclusionCriteria 
Details  1. Patients Below 30 years and Above 70 years.
2. Patients with Associated especially with Complication in Type-2 Diabetes Mellitus Like Irreversible Pathology, Chronic Kidney Disease, Cardio Vascular Disorder Etc.
3. Pregnant & Lactating Women’s During Study are excluded.
4. Patients Taking Antidiabetic Medicine from More Than 24 Months 0f Any Other Pathies to Control Blood Sugar Level.
5. Patients with Juvenile Diabetes or Insulin Dependent Diabetes are Excluded.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To the Study Clinical Presentation of Type-2 Diabetes Mellitus.  9 Months 
 
Secondary Outcome  
Outcome  TimePoints 
2.To Study the Indicated Homoeopathic Medicines in the Management of Type-2 Diabetes Mellitus.  9 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BRIEF RESUME ON INTENDED WORK

 

6.1 NEED FOR STUDY

 

      I Have Seen Cases of Type-2 Diabetes Mellitus in O.P.D of Chandravatiben Dhansukhlal Pachchigar College of Homoeopathic Medicine and Hospital. Its Prevalence Rate is High. So, I am Willing to Elaborate and Highlights the Indicated Remedy on The Basis of Individualization in type-2 Diabetes Mellitus.

 

 

 

 

 

 

 

 

 

 

 

 

 


 

6.2 REVIEW OF LITERATURE

 

  INTRODUCTION

 

       Diabetes mellitus is a complex metabolic disorder characterized by chronic hyperglycaemia due to relative insulin deficiency, resistance or both. In 2017, the International Diabetes Federation estimated that 425 million people (1 in 11 of the global population) had diabetes, and estimates an increase to 693 million by 2045.

      Diabetes is associated with a number of short and long-term complications that reduce quality of life and life expectancy, and are associated with major health costs. These include acute metabolic disturbance, macrovascular disease (leading to an increased prevalence of coronary artery disease, peripheral vascular disease and stroke), and microvascular damage causing retinopathy, nephropathy and neuropathy.

      Diabetes was responsible for approximately 4 million deaths or 10.7% of all deaths in 2017, outnumbering the combined number of global deaths from human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), tuberculosis and malaria. A diagnosis of diabetes in a man or woman at the age of 55 years reduces life expectancy by 5 and 6 years, respectively. By contrast, type 2 diabetes diagnosed after the age of 80 years has a limited effect on life expectancy, Heartdisease is the most common cause of death

Accounts for 2/3rd of all Death with Type-2 DM Aged 65 years or Older. (1)


ETIOLOGY

      Type 2 diabetes Mellitus (T2DM) accounts for around 90Percent of all cases of diabetes. In T2DM, the response to insulin is diminished, and this is defined as insulin resistance. During this state, insulin is ineffective and is initially countered by an increase in insulin production to maintain glucose homeostasis, but over time, insulin production decreases, resulting in T2DM. T2DM is most commonly seen in persons older than 45 years. Still, it is increasingly seen in children, adolescents, and younger adults due to rising levels of obesity, physical inactivity, and energy dense diet.  (2)

PATHOPHYSIOLOGY

      Type-2 Diabetes Mellitus Is an insulin-resistance condition with associated beta-cell dysfunction. Initially, there is a compensatory increase in insulin secretion, which maintains glucose levels in the normal range. As the disease progresses, beta cells change, and insulin secretion is unable to maintain glucose homeostasis, producing Hyperglycaemia. Most of the patients with T2DM are obese or have a higher body fat percentage, distributed predominantly in the abdominal region. This adipose tissue itself promotes insulin resistance through various inflammatory mechanisms, including increased FFA release and adipokine dysregulation. Lack of physical activity, prior GDM in those with hypertension or dyslipidaemia also increases the risk of developing T2DM. Evolving data suggest a role for adipokine dysregulation, inflammation, abnormal incretin biology with decreased incretins

Such as glucagon like peptide-1 or incretin resistance, hyperglucagonemia increases renal glucose absorption.  (2)

CLINICAL APPROACH TO THE PATIENT WITH DIABETES

·       Presentation

      Presentation may be acute, subacute or asymptomatic, or an individual may present with a complication of diabetes.

·       Acute presentation

      Children and young adults often present with a 2-6-week history of the classic triad of symptoms. Polyuria due to the osmotic diuresis that results when blood glucose levels exceed the renal threshold thirst and polydipsia due to the resulting loss of fluid and electrolytes weight less due to fluid depletion and accelerated breakdown of fat and muticle secondary to insulin deficiency. Ketonuria is often present in young people and may progress to ketoacidosis if these early symptoms are not recognized and treated

·       Subacute presentation

      The clinical onset may be prolonged over several months or years, particularly in older people. Thirst, polyuria and weight loss are usually present, but the individual may complain of other symptoms such as lack of energy, visual blurring (owing to glucose-induced changes in refraction), or pruritus vulvae or balanitis due to Candida infection.

·       Asymptomatic diabetes

        It is estimated that approximately half of people with diabetes are unaware of their condition. This proportion varies across the world. from about a third in high-income countries to three-quarters in some low-income countries. Consequently, up to one-third of diagnoses are made as an incidental finding and several countries have introduced screening programmes to identify those with Asymptomatic undiagnosed diabetes. (1)

INVESTIGATION

1.Blood Glucose estimation

       In Non diabetes, Blood glucose levels are 70-100mg/dl.

   A] Random blood Sugar (RBS) : If Less than140mg Normal , More than 200mg indicate Type-2  Diabetes Mellitus and between 140-200 mg GTT is required

   B] Fasting blood Sugar: Normal Less than 100mg, Diabetes if More than 126mg. If In Between 101-125mg than Prediabetes.

   C] Post prandial Blood sugar: Normal less than 140mg. Diabetes more than 200mg .

2. Two-Hour Oral Glucose Tolerance Test (OGTT)

        In this test, the plasma glucose level is measured before and 2 hours after the ingestion of 75 gm of glucose. DM is diagnosed if the plasma glucose (PG) level in the 2-hour sample is more than 200 mg/dL (11.1 mmol/L). It is also a standard test but is inconvenient and more costly than FPG and has major variability issues. Patients need to consume a diet with at least 150 g per day of carbohydrates for 3 to 5 days and not take any medications that can impact glucose tolerance, such as steroids and thiazide diuretics

 

 


3.Glycated Haemoglobin (Hb) A1C

This test gives an average of blood glucose over the last 2 to 3 months. Patients with a Hb A1C greater than 6.5 (48 mmol/mol) are diagnosed as having DM.

4. Urine Examination: Blood sugar level crosses 180mg sugar appear in urine.

5. Self monitoring Device : “Accucheck” Is used. (3)

COMPLICATIONS

      Persistent hyperglycaemia in uncontrolled diabetes mellitus can cause several complications, both acute and chronic. Diabetes mellitus is one of the leading causes of cardiovascular disease (CVD), blindness, kidney failure, and amputation of lower limbs. Acute complications include hypoglycaemia, diabetic ketoacidosis, hyperglycaemic hyperosmolar state, and hyperglycaemic diabetic coma. Chronic microvascular complications are nephropathy, neuropathy, and retinopathy, whereas chronic macro vascular complications are coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease. (2)

GENERAL MANAGEMENT

·       Elimination of the catabolic state and its symptoms

·       Elimination of glycosuria

·       Achievement of pre-prandial and post-prandial glycaemia as indicated by normal HbA1C

·       To prevent or retard the progression of complications associated With diabetes.

·       Prevent metabolic crises like ketoacidosis and hypoglycaemia

·       Maintain normal growth and body weight

·       Encourage self-reliance and self-care

·       Ensure optimum quality of life. (3)


  

HOMOEOPATHIC MANAGEMENT

       I.          Acetic Acid :- Diabetes with anaemia, burning thirst and debility.

     II.          Alloxanum :- Diabetes with Osteoporosis, muscular weakness, glycosuria without hyperglycaemia.

   III.          Apis :- Diabetes with pain in tendoachilles

  IV.          Carbo veg, Kreosotum, Sec-cor :- Humid gangrene of diabetics, collapse, persistent epistaxis

    V.          Chionanthus :- Diabetes with hepatic troubles, enlarged liver and spleen.

  VI.          Chimaphila :- Diabetes with prostatic enlargement, unable to urinate unless feet are wide apart, burning scanty urine with mucopurulent sediment.

VII.          Fluoric Acid and Aur met :- Diabetes associated with acquired or hereditary syphilis.

VIII.          Helonias:- Diabetes becoming rapidly grave, melancholic pt., thirst, restless. Emaciated.

  IX.          Ignatia and Nat Phos :- Diabetes of nervous origin, pt. has silent grief.

    X.          Kreosotum:- General action in diabetic gangrene, ulcer with offensive discharge.

  XI.          Lycopus :- Diabetes with heart troubles.

XII.          Lactic acid and Elaps :- Diabetes with strong elimination of uric acid in urine, HTN, gouty modalities.

XIII.          Plumbum met :- Diabetes with paralytic tendency.

XIV.          Phos acid :- Diabetes of nervous origin with impotency.

XV.          Thyroidinum :- Diabetes with h/o of allergic manifestations, stressful life.

  Uranium nit:- Diabetes with assimilative disorders and great emaciation.  (4) (5) (6)

6.3 AIM OF THE STUDY

           To Explore the Effectiveness of Indicated Homoeopathic in Management of   Type - 2 Diabetes Mellitus.                 

           6.4 OBJECTIVES OF THE STUDY

1.     To the Study Clinical Presentation of Type-2 Diabetes Mellitus.

2.     To Study the Indicated Homoeopathic Medicines in the Management of Type-2 Diabetes Mellitus.


 
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